Prosonix claimed that the technology, which was made commercially available this month, uses a highly specialised new variant of the company’s sonocrystallisation technique to make active pharmaceutical ingredient (API) particles without mechanically disruptive high-energy milling or micronisation.
According to David Hipkiss, CEO of Prosonix, this approach produces crystalline particles that are free of the variability introduced by traditional physical processing methods. Mr Hipkiss also stressed the benefits the UMAX approach can offer to drugmakers in terms of wider product life-cycle management issues.
Mr Hipkiss said: “The milling process delivers amorphous unstable material, which in turn leads to significant batch to batch variation and variable drug product performance.
“Milling is notoriously difficult to scale up and preserve early stage clinical performances and the root cause of many current customer woes is the fact they have milled the API. This can kill products in late stages.
“The ideal particles for inhalation are small, crystalline, stable and excipient free. UMAX [ultrasound mediated amorphous to x-alline transition]… can deliver best in class performance for new products, or enable generic bioequivalence.”
According to Mr Hipkiss, UMAX particles double the dose of an API from the same mass of starting material and cited new US rules restricting use of long-acting beta agonists (LABA) as a monotherapy as an area of application.
He added: “We can half the content of a LABA in a UMAX formulation compared to the original formulation yet get the same mass of LABA out of the device as comes from the original formulation resulting in a safer product.
“UMAX’ ability to produce particles combining two or more APIs can transform combination inhalation therapy…confirming we can deliver uniform and constant ratios of Fluticasone and Salmeterol across the lung making a safer and more syngergistic product.”